Goals
The objectives of the prestation ISO 15378 certification: Certification of primary packaging materials :
- Ensure the safety of patients and users of packaging materials
- Ensure compliance with good manufacturing practices for packaging materials
The certification of quality management for primary packaging materials for medicinal products governs the manufacture of primary packaging materials for medicines. This international standard establishes the conditions and good manufacturing practices for pharmaceutical packaging to ensure the safety of users.
This certification provides a management tool that helps harmonize the practices of the supply chain upstream of the pharmaceutical industry.
Who is the certification of quality management for primary packaging materials for medicinal products for?
The ISO 15378 standard is aimed at laboratories and manufacturers of packaging for medicines.
The benefits
The certification of quality management for primary packaging materials for medicinal products offers numerous advantages for your structure and allows you to:
- Ensure patient safety by limiting the risk of contamination of products in direct contact with packaging
- Ensure that pharmaceutical packaging materials comply with the requirements of the pharmaceutical industry regarding medicines
- Certify that recognized GMP rules are respected and that your company has an effective and efficient management system
- Optimize the profitability of your organisation through efficient organisation
- Enable the identification and reduction of risks and manufacturing errors to maintain the safety of your staff, your company, and users
- Enhance the quality of your production with your partners and customers
- Ensure compliance with good manufacturing practices for packaging materials
The certification of quality management for primary packaging materials for medicinal products governs the manufacture of primary packaging materials for medicines. This international standard establishes the conditions and good manufacturing practices for pharmaceutical packaging to ensure the safety of users.
This certification provides a management tool that helps harmonize the practices of the supply chain upstream of the pharmaceutical industry.
Who is the certification of quality management for primary packaging materials for medicinal products for?
The ISO 15378 standard is aimed at laboratories and manufacturers of packaging for medicines.
The benefits
The certification of quality management for primary packaging materials for medicinal products offers numerous advantages for your structure and allows you to:
- Ensure patient safety by limiting the risk of contamination of products in direct contact with packaging
- Ensure that pharmaceutical packaging materials comply with the requirements of the pharmaceutical industry regarding medicines
- Certify that recognized GMP rules are respected and that your company has an effective and efficient management system
- Optimize the profitability of your organisation through efficient organisation
- Enable the identification and reduction of risks and manufacturing errors to maintain the safety of your staff, your company, and users
- Enhance the quality of your production with your partners and customers
Description
Certification of primary packaging items for medicines is an essential element in ensuring the protection of patients and users.
Primary packaging refers to the container with which the medicine is in direct contact. It is therefore only natural to pay particular attention to it. Medicines are very fragile and sometimes dangerous products that require special attention when handled.
Satisfying the quality and safety requirements of packaging in the pharmaceutical industry is a key challenge for all companies in this sector.
Characteristics
The ISO 15378 standard is for companies a common and internationally recognized management tool. This certification allows a company to demonstrate its commitment to the safety of pharmaceutical product packaging. It meets the requirements of ISO 9001 while taking into account Good Manufacturing Practices (GMP).
Steps and processes
To obtain certification, Apave Certification supports you during the 6 steps leading to the issuance of the ISO 15378 certificate:
1. Initial certification request
2. Audit planning between the audited organisation & Apave Certification:
3. Initial certification audit
4. Certification decision
5. Certificate issuance
6. Annual follow-up audit
Primary packaging refers to the container with which the medicine is in direct contact. It is therefore only natural to pay particular attention to it. Medicines are very fragile and sometimes dangerous products that require special attention when handled.
Satisfying the quality and safety requirements of packaging in the pharmaceutical industry is a key challenge for all companies in this sector.
Characteristics
The ISO 15378 standard is for companies a common and internationally recognized management tool. This certification allows a company to demonstrate its commitment to the safety of pharmaceutical product packaging. It meets the requirements of ISO 9001 while taking into account Good Manufacturing Practices (GMP).
Steps and processes
To obtain certification, Apave Certification supports you during the 6 steps leading to the issuance of the ISO 15378 certificate:
1. Initial certification request
2. Audit planning between the audited organisation & Apave Certification:
3. Initial certification audit
4. Certification decision
5. Certificate issuance
6. Annual follow-up audit
Periodicity
ISO 15378 certification is a voluntary process that reflects an organisation's commitment to society.
ISO 15378 certificates are valid for three years.
Renewal of the certification requires a renewal audit.
ISO 15378 certificates are valid for three years.
Renewal of the certification requires a renewal audit.
Prestation
ISO 15378 certification: Certification of primary packaging materials
Ref : TSYS0320
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